RECRUITING

A Study of PET Adapted Therapy and Non-invasive Monitoring for Previously Untreated Limited Stage Diffuse Large B Cell Lymphoma

Talk to us

Conditions

DLBCL

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The overarching goals of this study are to measure levels of circulating tumor DNA (ctDNA) in patients with early stage diffuse large B cell lymphoma (DLBCL), to assess the change in ctDNA during treatment in order to prospectively identify markers of treatment failure, and to use ctDNA as a future tool for response adapted therapy.

Official Title

A Phase II Study of PET Adapted Therapy and Non-invasive Monitoring for Previously Untreated Limited Stage Diffuse Large B Cell Lymphoma

Quick Facts

Study Start:2019-05-08
Study Completion:2026-06-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03758989

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Previously untreated limited stage non bulky DLBCL; defined as limited stage by routine staging criteria in lymphoma involving FDG-PET and bone marrow biopsies (the Lugano criteria)\[21\]
  2. * Patients with grade 3B follicular lymphoma and transformed indolent lymphoma are included
  3. * Ages ≥ 18
  4. * Measurable disease, assessable by radiographic examination with FDG-PET showing involvement
  5. * Access to archived or fresh/frozen tumor biopsies
  6. * No uncontrolled medical comorbidities
  7. * Adequate cardiac function (EF \> or equal to 50%), no unstable angina
  8. * Adequate renal function (GFR \> 60)
  9. * Adequate liver function (liver function tests should be no greater than 2 x upper limit of normal) including normal bilirubin levels, no greater than 2 x upper limit of normal unless patient has a history of Gilbert's disease
  10. * Adequate marrow reserves as indicated by complete blood count in the judgment of the treating investigator
  1. * Pregnancy, positive serum HCG within 28 days of enrollment, or breast-feeding
  2. * Bulky disease greater than 10 cm in any dimension

Contacts and Locations

Study Contact

Robin Boerman
CONTACT
585-273-1507
Robin_Boerman@URMC.Rochester.edu

Principal Investigator

Carla Casulo
PRINCIPAL_INVESTIGATOR
University of Rochester

Study Locations (Sites)

University of Rochester
Rochester, New York, 14642
United States

Collaborators and Investigators

Sponsor: University of Rochester

  • Carla Casulo, PRINCIPAL_INVESTIGATOR, University of Rochester

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-05-08
Study Completion Date2026-06-01

Study Record Updates

Study Start Date2019-05-08
Study Completion Date2026-06-01

Terms related to this study

Additional Relevant MeSH Terms

  • DLBCL